Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma (BVR)

July 15, 2015 updated by: Jonathan Friedberg, University of Rochester

Pilot Study of Bortezomib, Bendamustine and Rituximab for Patients With Relapsed or Refractory, Indolent or Mantle Cell Non-Hodgkin's Lymphoma

The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Nebraska Medical Center
    • New York
      • New York, New York, United States, 10021
        • Cornell Wiell Medical College
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center (James P. Wilmot Cancer Center)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Voluntary written informed consent before performance of any study-specific procedure not part of routine medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Female subject is either post-menopausal or surgically sterilized or willing to use acceptable method of birth control for duration of study.
  • Male subject agrees to use acceptable method for contraception for duration of study.

  • Histologically-confirmed indolent or mantle cell lymphoma, utilizing the World Health Organization (WHO) classification. The biopsy must fulfill one of the following criteria:

    • Follicular lymphoma, grades 1-3
    • Marginal zone lymphoma
    • Small lymphocytic lymphoma (circulating lymphocyte count must be < 5,000)
    • Lymphoplasmacytic lymphoma
    • Mantle cell lymphoma [confirmed by cyclin D1+ or FISH for t(11;14)]
  • Age ≥ 18 years
  • Must have received at least one prior chemotherapy regimen for lymphoma. Patients treated only with antibody therapy or only with radiation therapy are not eligible.
  • Zubrod performance status ≤ 3
  • Patients must have measurable disease or an indication to receive additional therapy

Exclusion Criteria:

  • Patient has platelet count of ≤75,000/mm^3 within 14 days before enrollment.
  • Patient has absolute neutrophil count of < 1,000/mm^3 within 14 days before enrollment.
  • Patient has calculated or measured creatinine clearance of <30 mL/minute within 14 days before enrollment.
  • Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
  • Patient has hypersensitivity to boron or mannitol
  • Female subject is pregnant or breast-feeding. Confirmation subject is not pregnant must be established by negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
  • Patient has received chemotherapy or antibody therapy within 28 days before enrollment
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • Patient has received other investigational drugs with 14 days before enrollment
  • Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
  • Prior exposure to bendamustine
  • Prior exposure to bortezomib if Time to Progression (TTP) after bortezomib containing regimen was < 6 months. If TTP after bortezomib containing regimen was > 6 months, then patient is allowed to enroll on the study.
  • Patient has concomitant active malignancy requiring therapy
  • Patient is known to be HIV positive (test result not required for enrollment).
  • History of solid organ transplantation, or post transplant lymphoproliferative disorder
  • Patient has history of allogeneic stem cell transplantation.
  • Patient has history of autologous stem cell transplantation or radioimmunotherapy within the previous 4 months.
  • Patient has received any other investigational drugs within 14 days prior to enrollment
  • History of, or clinically apparent CNS lymphoma
  • Any clinically significant abnormality in screening blood chemistry, hematology, or urinalysis results that, in the judgment of the investigator, would impede adequate evaluation of adverse events and/or response to treatment, or that requires aggressive intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lymphoma Subjects receiving protocol therapy
Subjects that met all eligibility criteria and were treated with Bendamustine, Rituxan and Bortezomib.
Drug: bortezomib
1.3 mg/m^2 on days 1, 4, 8, 11
Other Names:
  • Velcade
Drug: bendamustine
90 mg/m^2 days 1 and 4
Other Names:
  • Treanda
Drug: rituximab
375 mg/m^2 day 1
Other Names:
  • Rituxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Progression Free Survival at 2 Years
Time Frame: Two years
To determine the progression-free survival following treatment with the BVR combination in patients with relapsed or refractory indolent and mantle cell non-Hodgkin lymphoma.
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity of Drug Combination in the Subjects
Time Frame: Two years
Two years
Overall Response Rate (ORR)
Time Frame: Two years
Overall response rate (ORR)to protocol treatment - Partial response, Complete response, etc.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Millennium Pharmaceuticals, Inc.
Cephalon

Investigators

  • Principal Investigator: Jonathan Friedberg, MD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

October 18, 2007

First Submitted That Met QC Criteria

October 18, 2007

First Posted (Estimate)

October 22, 2007

Study Record Updates

Last Update Posted (Estimate)

August 6, 2015

Last Update Submitted That Met QC Criteria

July 15, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULYM07054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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